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New treatment option for Traumatic Brain Injury
Official title Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
ClinicalTrials.gov ID: NCT06293300
What this study is testing
What is BoNT A?
BoNT A is an investigational medicine, being studied as a potential treatment for traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Recruit and enroll male and female people, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
- ≥18 years of age who are able to consent.
- Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (\>1 year).
- Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted...
- people must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
You likely can't join if
- Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris...
- Patients who are participating in another study with an investigational drug within one month prior to screening.
- Pregnant individuals. Pregnant people will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks...
- Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.
See the full eligibility criteria
- Recruit and enroll male and female people, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
- ≥18 years of age who are able to consent.
- Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (\>1 year).
- Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can...
- people must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
- English as primary language (by self-report).
- Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.
- Patients who are participating in another study with an investigational drug within one month prior to screening.
- Pregnant individuals. Pregnant people will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy...
- Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.